BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1111668 · Received August 13, 2008

    Report

    Report Number
    1823260-2008-06161
    Event Type
    Malfunction
    Date Received
    August 13, 2008
    Date of Event
    August 5, 2008
    Report Date
    August 13, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED THE CUSTOMER OBTAINED DISCREPANT BACK TO BACK BLOOD GLUCOSE RESULTS OF 140 MG/DL, 91 MG/DL, 35 MG/DL AND 236 MG/DL WHEN ALL TESTS WERE PERFORMED WITHIN 10 MINUTES ON THE ADVANTAGE SYSTEM. NO ACTIONS WERE REPORTED TAKEN OR TREATMENT RECEIVED. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE SUSPECT DEVICE AND REPLACEMENT PRODUCT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK COMFORT CURVE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS - LFR LFR ROCHE DIAGNOSTICS 550537

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR RENAGEL| PROCARDIA| HEMODIALYSIS| PLAVIX| LASIX| NEPHRO - CAPSULES| COREG| TYLENOL| PHOSLO| "COLASE"| NOVOLOG 142 UNITS DAILY